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Drugs

The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States

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FDA launches new adverse event look-up tool

As part of a commitment to modernization and transparency, the agency is offering direct access to product safety data. All submitted reports are now consolidated into one streamlined, user-friendly dashboard for scientists, researchers, and the public.

Consumer Contact Information Drug Alerts and Statements What's New Related to Drugs

Drugs@FDA

Find information about most FDA-approved prescription, generic, and over-the-counter drug products.

Drug Shortages

Find information about drug shortages caused by manufacturing and quality problems, delays, and discontinuations.

National Drug Code Directory Search

Find information about finished drug products, unfinished drugs, and compounded drug products.

Orange Book

The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness.

Graphic with a light blue and white background. There is a text overlay reading Public Meeting, April 23, 2026

FDA to hold meeting about increasing access to nonprescription drugs

Public meeting will focus on opportunities to improve access

A decorative image with a blue border and the words 'DRUG APPROVAL: New Indication' in dark blue text. Red and white capsules and clear bubbles float in the background.

New treatment targets rare kidney disease for the first time

Therapy now includes children eight and older with FSGS without nephrotic syndrome

A man in a blue shirt with his eyes closed, leaning forward and pinching the bridge of his nose as if in pain or from stress.

Call-to-action encourages new uses for testosterone replacement therapy

Agency promotes exploring low libido treatments for men with hypogonadism

Drug Information, Safety, and Availability

Medication Guides, Drug Safety Communications, Shortages, Recalls

Drug Approvals and Databases

Drugs@FDA, Orange Book, National Drug Code, Recent drug approvals

Drug Development and Review Process

Drug applications, submissions, manufacturing, and small business help

Guidance, Compliance, and Regulatory Information

Guidances, warning letters, drug compounding, international information, registration and listing

Regulatory Science and Research

CDER research programs, initiatives, and resources

Emergency Preparedness

Prepare and respond to natural disasters, nuclear and chemical attacks

Updates, News, Events, and Training

Recent approvals, meetings, workshops, blogs, podcasts, stay connected

About the Center for Drug Evaluation and Research (CDER)

Our role, mission, organization, history, leadership, job openings

Center

Meeting

Apr 23

FDA Public Meeting on Increasing Access to Nonprescription Drugs

Webcast

Apr 29

FDA Webinar on the RCT-DUPLICATE Initiative: Emulating Randomized Clinical Trials with Non-Randomized Real-World Data Studies

Biosimilars Education Initiative

Learn how biosimilars are safe and effective treatment options

Opioids

Reducing the impact of opioid misuse and abuse

Generics

Ensuring access to safe, affordable, and effective generic drugs

Warning Letters

Warning and Notice of Violation Letters to Pharmaceutical Companies

Guidances

FDA's current thinking on drug development and review activities

Drug Shortages

Search the database, learn about root causes and potential solutions

Resources

Information for consumers, health professionals, and industry

Disposal of Unused Medicines

Learn how to properly get rid of unused or expired medication

CENTER FOR DRUG EVALUATION AND RESEARCH

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Building 51, Room 1109
Silver Spring, MD 20993

druginfo@fda.hhs.gov

Toll Free

(855) 543-3784

(301) 796-3400

Hours Available

Center for Drug Evaluation and Research (CDER)

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FOR UPDATES ON X FOLLOW

@FDA_Drug_Info

Your source for the latest drug information.
Know the moment it happens.

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